Method of treating hidradentitis suppurativa with il-17 antagonists

Pending Publication Date: 2020-09-03
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes a new antibody called secukinumab that has very high affinity for a protein called interleukin-17A (IL-17A). This antibody can inhibit the biological activity of IL-17A at a very low concentration. It also has a long half-life, meaning it can be administered less frequently, which makes it useful for treating chronic disorders like hematopoietic stem cell disorders. Overall, the technical effect of this patent is the creation of a powerful and effective treatment for chronic disorders that targets a specific protein.

Problems solved by technology

(2017), the patient's reported improvement in the number of boils, pain VAS, and pain / utility / handicap VAS was not well reproduced in the physician reported scores, and the patient's quality of life after treatment initiation did not improve, as reflected in the lack of change in the patient's Dermatology Life Quality Index (DLQI).
Moreover, neither Schuch et al.

Method used

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  • Method of treating hidradentitis suppurativa with il-17 antagonists
  • Method of treating hidradentitis suppurativa with il-17 antagonists
  • Method of treating hidradentitis suppurativa with il-17 antagonists

Examples

Experimental program
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Effect test

example 1

dies of Anti-IL-17 Antibodies in Treating HS

[0176]Early clinical evidence of the effects of an anti-IL-17 antibody, CJM112, supports the potential of an anti-IL-17 antibody as an effective therapy for patients with HS. Like secukinumab, CJM112 is a recombinant fully human anti-interleukin-17A monoclonal antibody of the IgG1 / κ isotype, developed for the potential treatment of autoimmune and inflammatory conditions. CJM112 binds with higher affinity to human homodimer IL-17A (6 pM) than secukinumab, and neutralizes the bioactivity of IL-17A in vitro.

[0177]This phase 2 study (CCJM112X2202) was a randomized, placebo controlled, double blind, multicenter study with two periods in patients with moderate to severe chronic HS in parallel groups conducted in USA, Denmark, Switzerland, Germany and the Netherlands. This study consisted of approximately 4 weeks screening period, two sequential treatment periods of 16 weeks (Period 1 and Extension Period 2) and approximately 12 weeks of follow-u...

example 2

Example 2A: Responder Rate Predictions in Heavy Subjects for Higher Dosage (450 mg) and More Frequent Dosing (Q2w) of Secukinumab

[0198]The purpose of the modeling and simulation (M&S) work in this Example is to investigate the simulated efficacy of secukinumab in heavy subjects following the two higher dosage regimens mentioned above, 450 Q4W and 300 Q2W. We report here modeling and simulation (M&S) work that investigated responder rate of PASI 75 and PASI 90 in patients ≥90 kg in bodyweight, using the standard regimen for secukinumab in psoriasis, i.e. 300 mg Q4W, in comparison to predicted response using higher dose regimens, i.e. 450 mg Q4W or 300 mg Q2W. The main objective of the work is to use model predicted (i.e. simulated) response rates to estimate the magnitude of improvement with the higher doses in heavier patients.

[0199]PASI data from studies CAIN457A2302 and CAIN457A2303 up to week 52 were used in this analysis. Only subjects ≥90 kg were used in the model building (n=6...

example 2b

b Dose-Response Modelling and Simulation for Heavy Patients

[0206]The modeling and simulation in this example consists of week 52 data from the secukinumab OPTIMIZE study. OPTIMIZE (NCT02409667) was a 52 week comparative, randomized, multicenter, open-label trial with blinded-assessment to evaluate the efficacy, safety and tolerability of secukinumab 300 mg SC in long-term treatment optimization in patients with moderate to severe chronic plaque-type psoriasis. In this study, suboptimal responders at Week 24, i.e., patients who reached PASI75 (i.e., a 75% reduction from baseline in PASI score) but did not reach PASI90 after 24 weeks under secukinumab 300 mg q4w were subsequently randomized to either secukinumab 300 mg q4w or secukinumab 300 mg q2w until Week 52.

[0207]The top panel of FIG. 5 displays the percentage of responders (Patients achieving PASI90, i.e., a 90% reduction from baseline in PASI score at Week 52) by treatment group (q2w or q4w) and weight category (90 kg) in that ...

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Abstract

The present disclosure relates to methods for treating Hidradenitis Suppurativa (HS) using IL-17 antagonists, e. g., secukinumab. Also disclosed herein are IL-17 antagonists, e.g., IL-17 antibodies, such as secukinumab, for treating HS patients, as well as medicaments, dosing regimens, pharmaceutical formulations, dosage forms, and kits for use in the disclosed uses and methods.

Description

RELATED APPLICATIONS[0001]This disclosure claims priority to U.S. Provisional Patent Application No. 62 / 588,687, filed Nov. 20, 2017, the disclosure of which is incorporated by reference herein in its entirety.TECHNICAL FIELD[0002]The present disclosure relates to methods for treating Hidradenitis suppurativa using IL-17 antagonists, e.g., secukinumab.BACKGROUND OF THE DISCLOSURE[0003]Hidradenitis suppurativa (HS) (also referred to as acne inversa or Verneuil's disease) is a chronic, recurring, inflammatory disease characterized by deep-seated nodules, sinus tracts, and abscesses that lead to fibrosis in the axillary, inguinal, breast-fold, and anogenital regions. (Revuz and Jemec (2016) Dermatol Clin 34:1-5; Jemec G B. (2012) N Engl J Med 366:158-64). It is associated with substantial pain and comorbidities, including metabolic, psychiatric, and autoimmune disorders, as well as an increased risk of skin cancer. (Revuz (2016); Shlyankevich et al. (2014) J Am Acad Dermatol 71:1144-50...

Claims

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Application Information

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IPC IPC(8): C07K16/24A61P17/00
CPCA61K2039/545C07K16/244A61P17/00A61K2039/505C07K2317/76A61P37/06A61P17/10
Inventor LOESCHE, CHRISTIANDE VERA JUAREZ, ANNA MARIABRUIN, GERARDEZZET, FARKAD
Owner NOVARTIS AG
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